Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve...

Background: Prosthesis-patient mismatch (PPM) has been demonstrated to affect the outcome of both surgical (SAVR) and transcatheter aortic valve replacement (TAVR) patients. Supra-annular transcatheter valves (SAV) appear to offer a superior solution to intra-annular valves (IAV) in this regard. However, data on the comparison of the intra-annular self-expanding (SE) NAVITOR and the intra-annular balloon-expandable (BE) Sapien 3 Ultra in small annuli are limited. Methods: A total of 179 patients with severe native aortic valve stenosis were treated with either the SE NAVITOR (SEV; n = 104) or the BE Sapien 3 Ultra (BEV; n = 75) between March 2019 and June 2024. We compared the clinical and hemodynamic outcomes of the cohort according to the implanted prostheses. BMI-adjusted PPM was defined in accordance with the VARC-3 recommendations. Results: The device success at 30 days was superior in patients treated with the NAVITOR prosthesis (94.2% vs. 80.0%, p < 0.001), mainly driven by a higher rate of elevated gradients in the BEV group. The post-procedural mean gradient (8.0 mmHg vs. 13.0 mmHg, p < 0.001) as well as the rate of moderate to severe prosthesis patient mismatch (12.2% vs. 33.3%, p = 0.002) was higher in BEV recipients while the rate of more than moderate paravalvular leakage (PVL) or Valve in Valve (VinV) due to PVL (1.0% vs. 1.3%, p = 1.000) was similar between both groups. Pacemaker implantations were numerically more common after SEV (18.4% vs. 8.5%, p = 0.110). There was a trend towards higher thirty-day all-cause mortality among patients treated with SAV (3.8% vs. 1.3%, p = 0.401). Conclusion: The NAVITOR system may offer a more favorable hemodynamic profile compared to the Sapien 3 Ultra device in patients with small aortic annuli.